Systems for the prevention of surgical site infections

ABSTRACT

A surgical access system facilitates access to a surgical site within a patient&#39;s body through an incision in the body. Surgical access systems can have at least one retention member and a fluid transportation member configured to deliver fluid to a surgical site or to remove fluid from a surgical site. In some embodiments, a surgical access device irrigates a surgical site to reduce surgical site infections and removes fluid from the surgical site to increase a physician&#39;s visibility into the surgical site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/186,141, now U.S. Pat. No. 10,085,734, entitled “SYSTEMS FOR THEPREVENTION OF SURGICAL SITE INFECTIONS” and filed on Jun. 17, 2016,which is a continuation of U.S. patent application Ser. No. 13/736,888,now U.S. Pat. No. 9,393,005, entitled “SYSTEMS FOR THE PREVENTION OFSURGICAL SITE INFECTIONS” and filed on Jan. 8, 2013, which claimspriority under 35 U.S.C. § 119(e) to U.S. Provisional Patent ApplicationNo. 61/585,052, entitled “METHOD AND DEVICE FOR THE PREVENTION OFINCISIONAL SURGICAL SITE INFECTIONS,” and filed Jan. 10, 2012; U.S.Provisional Patent Application No. 61/603,673, entitled “METHODS ANDDEVICES FOR THE PREVENTION OF INCISIONAL SURGICAL SITE INFECTIONS,” andfiled Feb. 27, 2012; U.S. Provisional Patent Application No. 61/620,813,entitled “METHOD AND DEVICE FOR THE PREVENTION OF INCISIONAL SURGICALSITE INFECTIONS,” and filed Apr. 5, 2012; and U.S. Provisional PatentApplication No. 61/651,263, entitled “METHODS AND DEVICES FOR THEPREVENTION OF INCISIONAL SURGICAL SITE INFECTIONS,” and filed May 24,2012, the entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The field of the present application pertains to medical devices, andmore particularly, to methods, systems, and devices to facilitate accessto a surgical site within a body.

Background

Formerly known as “wound infection,” surgical site infection (SSI) isgenerally defined by the Centers for Disease Control and Prevention(CDC) as an infection in the area of the surgical incision that occurswithin 30 days of an operation. The CDC further subdivides SSI into twogroups. The first group includes superficial and deep “incisional” SSI(ISSI). The second group includes “organ/space” SSI. These two groupsappear to be somewhat different phenomena with respect to etiology,physiology, pathogenesis, clinical presentation, and treatment. Of note,the term “wound infection,” as currently used in the medical colloquium,refers to and is more compatible with ISSI, as opposed to organ/spaceSSI.

ISSI affects approximately 3-4% of the more than 30 million operationsperformed in the U.S. each year. Although the state of current medicalcare has minimized the mortality associated with ISSI, the morbidity andassociated costs to the healthcare system remain significant. Onaverage, ISSI extends the length of an inpatient hospital stay by 9days, as well as introduces the added necessity and costs of outpatientwound management, which can reach upwards of 10,000-45,000 U.S. dollarsper patient. Estimates of the aggregate annual burden to the U.S.healthcare system exceed five billion U.S. dollars.

The diagnosis of SSI is usually made by a physician and is usually basedon the clinical finding of various signs and symptoms of infection atthe incisional site, such as pain, tenderness, swelling, redness,warmth, and purulent drainage. Various ancillary tests, such asmicrobial cultures or radiographic exams (e.g., computed tomographyscans), can aid in the diagnosis. The length of treatment can extend forweeks or even months.

Obese patients are particularly vulnerable to developing woundinfections, with a two to three fold increased risk relative to theoverall population. This is at least partially due to the poorvascularization of subcutaneous fat, reducing the delivery ofprophylactic intravenous (IV) antibiotics to the incision site.Furthermore, subcutaneous fat is an excellent media for the incubationof bacterial infection. With increasing rates of obesity worldwide, thiswill only further compound the problem of ISSI.

Another risk factor for the development of ISSI is the type of surgicalprocedure performed. For example, colorectal surgeries are associatedwith a baseline infection rate of 15-20%. This is a result of thecontaminated nature of the procedure, as fecal contents are oftenreleased into the operative field when colon, small bowel, or rectum iscut. Furthermore, colorectal surgery involves the manipulation andremoval of large organs (e.g. the colon), and consequently, largeincisions are often required to perform the procedures. ISSI risk isdirectly correlated with the size of surgical incision used to performthe case. These risks are further compounded when combined with otherrisk factors such as obesity. For example, the rates of wound infectionsin obese patients undergoing colorectal surgery increase to upwards of33%, representing a major burden to the healthcare system in terms ofthe quality and cost of services.

Prior surgical instruments and methods have been developed with the aimof reducing wound infections, yet the scope of the problem has not beenreduced. Some solutions have addressed the issue by implantingdegradable sponges in the incision to combat the development of woundinfections post-operatively. However, this approach led to increases inwound infection rates, as the immune system reacts poorly to the implantbecause the implant is a “foreign body.”

Surgeons have previously irrigated the incision or wound margins withfluids such as saline and/or antibiotics, but the practice has proved tobe disruptive to surgical progress, difficult to implement andstandardize in surgical practices, and consumes valuable time,increasing patient risk and increasing operative costs.

Barrier wound protectors have also been employed to prevent the egressof bacteria into the incision, but this is merely a passive approach,and considering the barrier protection must be removed to complete theoperation, the incision is inevitably exposed to the infectious contentscontained within the surgical field. Additionally, wound protectors maybe difficult to manipulate, especially when positioned in the surgicalfield. A further drawback is that the barrier can also trap bacteriaonto the wound surface, allowing bacteria to proliferate in the woundspace.

Considering the significant morbidity and cost associated with SSI, itis desirable to provide a way to reduce the occurrence of SSI that issuperior to the limitations of currently available commercial devices.

In select situations, a key aspect of surgery involves obtainingadequate surgical “exposure,” or alternatively, adequate visualizationand access to target anatomical landmarks and structures to be operatedupon. To achieve proper exposure, surgeons can use a variety of surgicalretractors generally configured to maximize the opening of the incisionand create space within the operative region (e.g. chest, abdomen,orbit, neck, and groin) to facilitate the completion of the surgicalprocedure.

One surgical retractor used in abdominal surgery involves a top ring,bottom ring, and flexible tubular sheath disposed between the top andbottom rings. In numerous embodiments, manipulation of the top ring in avariety of ways (e.g., by rolling the sheath around the top ring) issometimes effective to shorten the sheath length and retract the edgesof the incision. In many cases, such surgical retractors incorporatebarrier wound protection, the disadvantages of which have already beendescribed.

The drawbacks of surgical retractors described in currently availablecommercial devices are numerous. They can be difficult to use, requiringadditional time and the manual application of forces that may bedifficult for surgeons to apply in an operative setting. They mayrequire more than 1 person to operate, decreasing focus on the operativefield, increasing operative time and personnel costs. In addition, dueto the unpredictable nature of a surgical operation, the initialincision size may not be ideal, thus requiring lengthening during thecourse of the procedure. Many commercially available surgical retractorsdo not allow for an increase in incision size with the device in site.Moreover, currently available commercial surgical retractors may employa design requiring a variety of sizes to accommodate the wide range ofincision sizes encountered during surgery. As a result, hospitals mayhave to stock a range of device sizes, and often multiple devices areused in a single procedure as the size of the incision may be increased.Using multiple devices may result in increased healthcare costs, surgeryduration, and infections.

BRIEF SUMMARY

It would therefore be desirable to provide improved surgical retractorswhich address at least some of the possible shortcomings of existingdevices. Moreover, it would also be desirable if improved surgicalretractors helped to reduce the incidence of SSI. At least some of theseobjectives are met by the exemplary embodiments described below. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, various embodiments may be carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other aspects oradvantages as may also be taught or suggested herein. For example, someembodiments reduce SSI but do not necessarily provide access tostructures upon which a physician needs to operate. Several of theembodiments improve upon prior art retractors by transforming theretractors into systems that reduce SSI. Several embodiments provideaccess to structures upon which a physician needs to operate but do notnecessarily reduce SSI.

Various embodiments described below are directed to surgical accessdevices that are adapted to facilitate access to a surgical site withina body of a patient through an incision in the body. The surgical accessdevice embodiments can comprise a first retention ring; a secondretention ring configured to expand from a collapsed configuration to anexpanded configuration; and a pliable membrane extending between thefirst retention ring and the second retention ring. The pliable membranecan be configured to expand the incision to facilitate access to thesurgical site. The surgical access device can also include a fluiddelivery member coupled with at least one of the first retention ring,the second retention ring or the pliable membrane for delivering fluidto the surgical site.

The first retention ring can be deformable. The first retention ring canalso be an expandable retention ring. In various embodiments, the secondretention ring is configured to selectively maintain the expandedconfiguration. In some embodiments, the second retention ring comprisesat least four linkages pivotably coupled to one another such thatexpanding the second retention ring causes the linkages to pivotrelative to each other.

The second retention ring can also comprise ratchet teeth configured toselectively maintain the expanded configuration. The second retentionring can also comprise at least one ratchet pawl configured toselectively maintain the expanded configuration by engaging at least aportion of the ratchet teeth. The surgical access device can alsoinclude a release member configured to disengage the ratchet pawl fromthe ratchet teeth to enable the second retention ring to return to thecollapsed configuration. In some embodiments, the surgical access devicecomprises a user interface button coupled to at least one of the ratchetteeth or to the ratchet pawl. The user interface button can beconfigured to disengage the ratchet pawl from the ratchet teeth toenable the second retention ring to return to the collapsedconfiguration.

The surgical access device can also include a locking mechanismconfigured to selectively lock the second retention ring in the expandedconfiguration. The locking mechanism can comprise an indentation and aprotrusion. The protrusion can be configured to engage the indentationto selectively lock the second retention ring in the expandedconfiguration.

In certain embodiments, the pliable membrane comprises a tubularmembrane, wherein the tubular membrane comprises a first end and asecond end. The first end is coupled to the first retention ring and thesecond end is coupled to the second retention ring. The fluid deliverymember can comprise a lumen with holes where the holes are configured todeliver fluid to the surgical site. The fluid delivery member can alsocomprise a porous medium and/or a perforated membrane.

In various embodiments, the surgical access device comprises a fluidremoval member coupled with at least one of the first retention ring,the second retention ring or the pliable membrane for removing fluidfrom the surgical site. The fluid removal member can comprise a suctionmember.

The first retention ring can be configured for advancement through theincision into the body. The second retention ring can be configured forplacement outside the body.

In at least one embodiment, a surgical access system is adapted tofacilitate access to a surgical site within a body of a patient throughan incision in the body. The surgical access system can comprise a firstretention ring configured for placement within the body at or near thesurgical site; a second retention ring configured for placement outsidethe body; and a pliable membrane extending between the first retentionring and the second retention ring. The system can also include a fluiddelivery inlet coupled with the pliable membrane for introducing fluidinto the surgical access system and at least one opening in the pliablemembrane, wherein the at least one opening is in fluid communicationwith the fluid delivery inlet to allow the fluid introduced into thefluid delivery inlet to exit the surgical access system. The system canalso include a fluid removal member coupled with at least one of thefirst retention ring or the pliable membrane for removing fluid from thesurgical site.

In some embodiments, the pliable membrane comprises a circumferentialfluid dispersion ring. In other embodiments, the pliable membranecomprises a fluid-permeable tube. The fluid-permeable tube can compriseopenings configured to deliver the fluid to the surgical site.

In select embodiments, the pliable membrane comprises a tubular membraneand a tube with at least one lumen disposed in a spiral direction aroundthe tubular membrane. A wire can be disposed inside at least a portionof the tube. In various embodiments, the surgical access systemcomprises a flow regulator in fluid communication with the fluiddelivery inlet.

In some surgical access systems, the pliable membrane comprises afluid-permeable material and the surgical access system is configured todeliver the fluid from the fluid delivery inlet to the fluid-permeablematerial. The fluid-permeable material can be configured to deliver thefluid to the surgical site. The fluid-permeable material can be a porousmedium. The surgical access system can also include a first fluidconduit member in fluid communication with the fluid delivery inlet. Thefluid removal member can comprise a second fluid conduit member coupledto the first retention ring. The first retention ring sometimescomprises a hollow ring. The second fluid conduit member can be in fluidcommunication with the hollow ring.

In several embodiments, the surgical access system comprises a suctiontube and the second fluid conduit member is in fluid communication withthe suction tube. The pliable membrane can comprise a tubular membrane.The tubular membrane can comprise an upper portion and a lower portion.The lower portion is closer than the upper portion to the firstretention ring. A first fluid conduit member can be in fluidcommunication with the upper portion, and a second fluid conduit membercan be in fluid communication with the lower portion.

In certain embodiments, the first retention ring and the secondretention ring are circular. The surgical access system comprises athird retention ring in several embodiments. The surgical access systemcan also comprise a fourth retention ring.

In various embodiments, a method for retracting tissue and providingfluid to a surgical site in a body during a surgical procedure comprisesadvancing a first retention ring into the body through an incision in acollapsed configuration and placing a second retention ring outside thebody, wherein the second retention ring is coupled to the firstretention ring by a pliable membrane. The method can also includeretracting the tissue using the pliable membrane and introducing thefluid into a fluid delivery inlet coupled to the pliable membrane suchthat the fluid exits the pliable membrane through at least one openingin the pliable membrane. The method can also include suctioning thefluid into the pliable membrane and removing the fluid from the body.

In several embodiments, a fluid conduit member is coupled to the firstretention ring and the method comprises suctioning the fluid into thefluid conduit member and removing the fluid from the body. The fluid cancomprise an antibiotic fluid. The fluid can also comprise a salinesolution.

In some embodiments, the method comprises expanding the second retentionring whereby expanding the second retention ring causes the pliablemembrane to retract the tissue around the incision. The second retentionring can comprise at least four linkages pivotably coupled to oneanother. Expanding the second retention ring can comprise pivoting theat least four linkages relative to each other. In various embodiments, awire is spirally wound around the pliable membrane and the retractingthe tissue comprises pulling the wire. In some embodiments, retractingthe tissue comprises inflating at least a portion of the pliablemembrane.

In multiple embodiments, a surgical access device that is adapted tofacilitate access to a surgical site through an incision in a patient'sbody comprises a first a first retention member, an expandable secondretention member, and a pliable membrane. The expandable secondretention member can have a collapsed configuration and an expandedconfiguration. The pliable membrane can have a first end, a second end,an inner layer and an outer layer. The first end can be coupled to thefirst retention member, and the second end can be coupled to the secondretention member. The inner layer and the outer layer form a space therebetween that carries a fluid. In these embodiments, when the pliablemembrane expands radially outward, it engages and expands the incisionwhen the second retention member is actuated into the expandedconfiguration.

Some embodiments include a pliable membrane that has a hydrophiliccoating disposed thereon, and the hydrophilic coating helps disperse thefluid along the membrane. One or more channels may be disposed on asurface of the pliable membrane such as the membrane's outer surface.The channels may direct the fluid along the pliable membrane. The fluidmay be delivered from the channels to tissue in the surgical site thatis adjacent the pliable membrane.

In several embodiments, the inner layer and outer layer of the pliablemembrane may be coupled together with a plurality of joined locationsthere between and this may prevent separation of the layers from oneanother. The joined locations may form a plurality of chambers in thespace, and the fluid may flow into and out of a chamber without passinginto another chamber. The pliable membrane may comprise a plurality ofperforations, and the fluid may exit the space via the plurality ofperforations. The plurality of perforations may comprise a first and asecond perforation. The first perforation may be fluidly disposed alonga first fluid path through the pliable membrane, and a secondperforation may be fluidly disposed along a second fluid path in thepliable membrane. The first fluid path may be fluidly independent of thesecond fluid path.

The access device may further comprise a fluid delivery member such asone or more tubes, that is fluidly coupled with the space. A porousmaterial may be disposed in the space between the layers. The device mayalso comprise a plurality of fluid flow channels that are disposed alongthe pliable membrane. The fluid flow along the fluid flow channels maybe selectively controllable. The fluid flow channels may be coupled to avacuum source, and the fluid may be removed from the surgical site viathe plurality of fluid flow channels when suction or a vacuum isapplied.

Certain embodiments include a surgical access device adapted tofacilitate access to a surgical site within a body of a patient throughan incision in the body. The surgical access device can include a firstretention member and a second retention member. The second retentionmember can be configured to expand from a collapsed configuration to anexpanded configuration. The second retention member can include at leastfour linkages pivotably coupled to one another such that actuation ofthe linkages causes the linkages to pivot relative to one anotherthereby radially expanding or collapsing the second retention member.The surgical access device can also include a pliable membrane extendingbetween the first retention member and the second retention member. Thepliable membrane can be configured to engage and expand the incision tofacilitate access to the surgical site when the second retention memberis in the expanded configuration.

In several embodiments, the second retention member is an expandableretention ring and the linkages are pivotably coupled together in aclosed shape. The first retention member can be a closed and deformableretention ring. The first retention member can also be a closed andexpandable retention ring. The second retention member can include alocking mechanism configured to selectively maintain the secondretention member in the expanded configuration. The locking mechanismcan comprise ratchet teeth on the second retention member configured toselectively maintain the expanded configuration. The locking mechanismcan comprise a ratchet pawl on the second retention member configured toselectively maintain the second retention member in the expandedconfiguration by engaging at least a portion of the ratchet teeth withthe ratchet pawl. Several surgical access device embodiments comprise arelease mechanism configured to disengage the ratchet pawl from theratchet teeth to enable the second retention member to return to thecollapsed configuration from the expanded configuration. Someembodiments include a user interface button operatively coupled to atleast one of the ratchet teeth or to the ratchet pawl, wherein actuationof the user interface button disengages the ratchet pawl from theratchet teeth to enable the second retention member to return to thecollapsed configuration from the expanded configuration.

In select embodiments, the locking mechanism comprises an indentationand a protrusion. The protrusion can be received in the indentation toselectively lock the second retention member in the expandedconfiguration.

The pliable membrane can include a tubular membrane that comprises afirst end and a second end. The first end can be coupled to the firstretention member and the second end can be coupled to the secondretention member.

In several embodiments, the first retention member is sized foradvancement through the incision into the body. The second retentionmember can be configured for placement outside the body.

In at least one embodiment, a surgical access device comprises a firstretention member and a second retention member having a collapsedconfiguration and an expanded configuration. The second retention membercan comprise at least three linkages pivotably coupled to one anothersuch that expanding the second retention member causes the linkages topivot relative to each other. The surgical access device can alsoinclude a pliable membrane extending between the first retention memberand the second retention member. The pliable membrane can be configuredto engage and expand the incision to facilitate access to the surgicalsite when the second retention member is in the expanded configuration.

In some embodiments, the second retention member is biased (e.g., springloaded) towards the expanded configuration. In other embodiments, thesecond retention member is biased (e.g., spring loaded) towards thecollapsed configuration. In some embodiments, each retention member is aretention ring that is noncircular.

Multiple embodiments include a first retention member and an expandableretention member having an expanded configuration and a collapsedconfiguration. The expandable retention member can comprise at leastfour linkages pivotably coupled to one another to form a closed shape,wherein actuation of the linkages causes the linkages to pivot relativeto each other thereby expanding the expandable retention member. Theembodiments can also include a pliable membrane extending between thefirst retention member and the expandable retention member, wherein thepliable membrane is adapted to engage tissue and the pliable membrane isconfigured to expand the incision to facilitate access to the surgicalsite when the expandable retention member is in the expandedconfiguration. Several embodiments comprise a radially expandablechannel extending axially along the pliable membrane to provide accessto the surgical site. Some embodiments include an expandable retentionmember that comprises at least ten linkages pivotably coupled to oneanother. Expandable retention members can include a living hinge thatpivotably couples at least two of the linkages to one another.

Select embodiments include a first retention member and a secondretention member coupled to the first retention member by a connector.The connector can be a pliable membrane, a rigid connector, or any othersuitable connector. The first retention member and the second retentionmember can be configured to expand the incision to provide access to thesurgical site. The surgical access embodiment can also include a fluiddelivery member coupled to the first retention member and a fluiddelivery inlet in fluid communication with the fluid delivery member forintroducing fluid into the surgical access system. The system can alsoinclude at least one opening in the fluid delivery member, wherein theat least one opening is in fluid communication with the fluid deliveryinlet to allow the fluid introduced into the fluid delivery inlet toexit the surgical access system. Several embodiments also include afluid removal member coupled with at least one of the first retentionmember, the second retention member, and the connector.

Multiple surgical access embodiments include a first retention memberconfigured for placement within the body at or near the surgical site, asecond retention member configured for placement outside the body, and apliable membrane extending between the first retention member and thesecond retention member. The embodiments can also include a fluiddelivery inlet coupled with the pliable membrane for introducing fluidinto the surgical access system and at least one opening in the pliablemembrane, wherein the at least one opening is in fluid communicationwith the fluid delivery inlet to allow the fluid introduced into thefluid delivery inlet to exit the surgical access system. The system canfurther include a fluid removal member coupled with at least one of thefirst retention member and the pliable membrane. The fluid removalmember can comprise an outlet conduit coupled to a medical suctiondevice.

In several embodiments, the pliable membrane comprises a fluid-permeablematerial. The surgical access system can be configured to deliver thefluid from the fluid delivery inlet to the fluid-permeable material. Thefluid-permeable material can be configured to deliver the fluid to thesurgical site. The fluid-permeable material can be a porous medium. Thepliable membrane can comprise a circumferential fluid dispersion member.

The pliable membrane can include a fluid-permeable tube. Thefluid-permeable tube can be disposed in a spiral direction around thepliable membrane and a wire can be disposed inside at least a portion ofthe fluid-permeable tube.

Some embodiments include at least one flow regulator in fluidcommunication with the fluid delivery inlet. A fluid conduit member canbe in fluid communication with the fluid delivery inlet. The fluidconduit member can be configured to be placed in fluid communicationwith a fluid source such as a saline bag. The first retention member andthe second retention member are circular in several embodiments.

Several embodiments include a first retention ring, a second retentionring, and a pliable membrane extending between the first retention ringand the second retention ring. The pliable membrane can comprise aninner wall and an outer wall, wherein the pliable membrane comprises aspace between at least a portion of the inner wall and the outer wall.The space can be configured to enable fluid to pass through at least aportion of the pliable membrane. A fluid delivery inlet can be coupledwith the pliable membrane for introducing the fluid into the surgicalaccess system. The fluid delivery inlet can be in fluid communicationwith the space. There can be at least one opening in the pliablemembrane, wherein the at least one opening is in fluid communicationwith the space to allow the fluid introduced into the fluid deliveryinlet to pass through the space and then exit the surgical access systemthrough the opening. A fluid removal member can be in fluidcommunication with the pliable membrane. The fluid removal member cancomprise an outlet conduit coupled to a medical suction device.

Several embodiments include a method for retracting tissue of a surgicalsite of a body. The method can include inserting at least a portion of asurgical access device into an incision, wherein the surgical accessdevice comprises a first retention member, a second retention member, apliable membrane coupled between the first retention member and thesecond retention member, and a fluid delivery inlet configured to beplaced in fluid communication with the pliable membrane. The method canalso include advancing the first retention member into the body throughthe incision and placing the second retention member outside the body.Several embodiments include retracting the tissue using the pliablemembrane and introducing fluid into the fluid delivery inlet such thatthe fluid exits the pliable membrane.

Methods can also include suctioning at least a portion of the fluid intothe surgical access device and removing the portion from the body. Inselect methods, a fluid conduit member is coupled to the first retentionmember, and the methods further comprise suctioning the fluid into thefluid conduit member and removing the fluid from the body. In somemethods, the fluid is an antibiotic fluid, a saline solution, adiagnostic agent, or a therapeutic agent.

Several method embodiments comprise expanding the second retentionmember, whereby expanding the second retention member causes the pliablemembrane to retract the tissue around the incision. The second retentionmember can comprise at least four linkages pivotably coupled to oneanother, and expanding the second retention member can comprise pivotingthe at least four linkages relative to each other. Expanding cancomprise increasing the inner diameter of the second retention member.Some methods include a wire that is spirally wound around the pliablemembrane and retracting the tissue comprises pulling the wire. In selectmethods, retracting the tissue comprises inflating at least a portion ofthe pliable membrane.

Several method embodiments for retracting tissue of a surgical site of abody comprise inserting at least a portion of a surgical access deviceinto an incision, wherein the surgical access device comprises a firstretention member, a second retention member, a pliable membrane coupledbetween the first retention member and the second retention member, anda fluid removal conduit coupled to the first retention member. Themethod can further comprise advancing the first retention member intothe body through the incision and placing the second retention memberoutside the body. The method can also comprise retracting the tissueusing the pliable membrane, suctioning a fluid into the surgical accessdevice, and removing the fluid from the body. Some methods includeintroducing fluid into the surgical access device such that the fluidexits the pliable membrane. A suction device can be coupled to the fluidremoval conduit.

Multiple methods for retracting tissue of a surgical include inserting aretraction device into an incision, retracting tissue, introducing fluidinto the retraction device, and forcing the fluid out of the retractiondevice into the surgical site. Forcing the fluid out of the retractiondevice can comprise creating sufficient pressure by positioning thefluid source sufficiently higher than the retraction device or surgicalsite such that gravity forces the fluid out of the retraction device.Forcing the fluid out of the retraction device can comprise forcing thefluid through a channel system that substantially circumscribes theretraction device. Forcing the fluid out of the retraction device canalso include forcing the fluid through a porous material. Variousmethods also include suctioning the fluid from the surgical site intothe retraction device and removing the fluid from the body. Theretraction device can include an upper portion and a lower portion thatare not in direct fluid communication, wherein forcing the fluid out ofthe retraction device comprises forcing the fluid out of the upperportion and suctioning the fluid from the surgical site comprisessuctioning the fluid into the lower portion.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic illustration of an incision in a patient'sbody;

FIG. 2 is a diagrammatic illustration of the incision illustrated inFIG. 1 after the incision has been at least partially expanded;

FIG. 3 is a partial cross-sectional view of one embodiment of a surgicalaccess device that is disposed in an incision and provides access to asurgical site;

FIG. 4 is a perspective view of an embodiment of a fluid irrigationsystem in the form of two rings connected by a flexible conduitcomprising a plurality of walls;

FIG. 5 is a cross-sectional view of an inlet conduit, pliable membrane,and second retention ring, according to one embodiment;

FIG. 6 is a cross-sectional view of a pliable membrane and firstretention ring, according to one embodiment;

FIG. 7 is a cross-sectional view that illustrates how a surgical accessdevice provides access through skin and subcutaneous fat in route to atarget site, according to one embodiment;

FIG. 8 is a cross-sectional view that illustrates an embodiment thatcomprises a third retention ring;

FIGS. 9a-9d illustrate top views of various retention ring embodimentswith different shapes;

FIG. 10 is a cross-sectional view that illustrates a surgical accessdevice wherein the fluid delivery member comprises a porous medium,according to one embodiment;

FIG. 11 is a cross-sectional view that illustrates a surgical accessdevice wherein the fluid delivery member comprises a porous medium,according to one embodiment;

FIG. 12 is a cross-sectional view of an embodiment in which the fluiddelivery member is located near the proximal end of a surgical accessdevice;

FIG. 13 is a cross-sectional view of an embodiment in which the fluiddelivery member is located near the distal end of a surgical accessdevice;

FIG. 14 is a perspective view of an embodiment in which a pliablemembrane comprises a tubular membrane and a routing tube with at leastone lumen;

FIGS. 15a-15c illustrate embodiments of holes, slits, and spiral slotsin various routing tubes;

FIG. 16 is a side view that illustrates an example routing tubeorientation angle, according to one embodiment;

FIG. 17 is a side view that illustrates another example routing tubeembodiment wherein a tubular membrane has a substantially cylindricalshape;

FIG. 18 is a side view of an embodiment wherein a pliable membraneincludes irrigation tubing;

FIG. 19 is a side view of an embodiment that comprises a flowcontrolling means such as a flow regulator;

FIG. 20 is a side view of an embodiment configured to expand an incisionby inflating chambers;

FIG. 21 is a perspective view of an embodiment configured to expand anincision by inflating chambers;

FIG. 22 is a side view of an embodiment wherein an expandable ring isconfigured to expand an incision;

FIG. 23 is a top view of an embodiment with an expandable ring in acollapsed configuration;

FIG. 24 is a top view of an embodiment with an expandable ring in anexpanded configuration;

FIG. 25 is a bottom view of approximately half of an expandable ringembodiment;

FIGS. 26-29 are flow charts illustrating exemplary method steps;

FIG. 30a is a top view of a portion of an expandable ring withnon-living pivots and living hinges, according to one embodiment;

FIG. 30b is a top view of a portion of an expandable ring with livingpivots and living hinges, according to one embodiment;

FIG. 31a is a top view of a completely expanded ring that is elliptical,according to one embodiment;

FIG. 31b is a top view of a completely collapsed ring that iselliptical, according to one embodiment;

FIG. 32 is a top view of a portion of an expandable ring with a lockingmechanism, according to one embodiment;

FIG. 33 is a cross-sectional view of a torsion spring and torsion springpin, according to one embodiment;

FIG. 34 is a top view of a portion of an expandable ring with a pivotlock, according to one embodiment;

FIG. 35 is a partial cross-sectional view of a pivot lock embodiment;

FIG. 36 is a top view of a portion of an expandable ring with a torsionspring assembly that creates a torsional force that expands theexpandable ring, according to one embodiment;

FIGS. 37-38 are top views of a portion of an expandable ring with anelastic member, according to one embodiment;

FIGS. 39-40 are top views of a retention member, according to oneembodiment;

FIG. 41 is a top view of an embodiment with two retention memberscoupled by a connector;

FIG. 42 is a top view of an adapter member that connects to pivots,according to one embodiment;

FIG. 43 is a cross-sectional view of an interface between an adaptermember and a pivot, according to one embodiment;

FIG. 44 is a side view of a surgical access device with channels,according to one embodiment;

FIG. 45 is a cross-sectional view of the embodiment shown in FIG. 44;

FIG. 46 is a side view of a surgical access device with joined layers,according to one embodiment;

FIG. 47 is a cross-sectional view of the embodiment shown in FIG. 46;

FIG. 48 is a side view of a surgical access device wherein a joinedlength generally isolates one perforation from another perforation,according to one embodiment;

FIG. 49 is a side view of another embodiment wherein joined lengthsgenerally isolate one perforation from another perforation;

FIG. 50 is a side view of a surgical access device wherein a member isdisposed inside a chamber to maintain the chamber's patency, accordingto one embodiment;

FIG. 51 is a side view of a surgical access device with selective fluiddelivery, according to one embodiment;

FIG. 52 is a side view of a surgical access device with selective fluidremoval, according to one embodiment; and

FIG. 53 is a side view of a surgical access device wherein a member isdisposed inside fluid removal chamber to maintain the chamber's patency,according to one embodiment.

DETAILED DESCRIPTION

Although certain embodiments and examples are disclosed below, inventivesubject matter extends beyond the specifically disclosed embodiments toother alternative embodiments and/or uses, and to modifications andequivalents thereof. Thus, the scope of the claims appended hereto isnot limited by any of the particular embodiments described below. Forexample, in any method or process disclosed herein, the acts oroperations of the method or process may be performed in any suitablesequence and are not necessarily limited to any particular disclosedsequence. Various operations may be described as multiple discreteoperations in turn, in a manner that may be helpful in understandingcertain embodiments; however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures, systems, and/or devices described hereinmay be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

Referring now to FIGS. 1-3, physicians incise a portion of a patient'sbody to facilitate access to a surgical site. For example, the surgicalsite may be deep within the patient's body such that the physician mustincise and dissect through the patient's skin 2, subcutaneous tissue,and deep soft tissue (such as fascia and muscle) in order to reach anorgan on which the physician needs to operate. Referring now to FIG. 1,incisions 4 are typically too narrow to facilitate access to a surgicalsite. Surgical access devices 8 a often expand the incision 4 tofacilitate access to the surgical site. For example, surgical accessdevices 8 a may be wound retractors that retract the tissue around theincision 4 such that the incision width 6 is larger after the surgicalaccess device 8 a retracts the tissue than before the surgical accessdevice 8 a retracts the tissue. FIG. 2 shows an example of an expandedincision, although expanded incisions may have a wide variety of shapesand sizes. In other embodiments, the surgical access device 8 a does notretract the tissue around the incision 4, but generally conforms to theshape of the incision 4 and generally takes the shape of the incisedtissue from the skin to the surgical site.

FIG. 3 illustrates one embodiment of a surgical access device 8 a thatis disposed in an incision and provides access to a surgical site.Exemplary surgical access devices may include surgical retractors thatretract the tissue around the incision 4 to form a wider incision widththan the initial incision. Other exemplary surgical access devices donot retract tissue or make the incision wider, but deliver fluid to thesurgical site and/or remove fluid from the surgical site. In FIG. 3, thepatient's body is shown as a cross section while the surgical accessdevice 8 a is not shown as a cross sectional view. The surgical accessdevice 8 a comprises an upper member 10 and a lower member 12. A sheath14 extends between the upper member 10 and the lower member 12. In anembodiment, the sheath 14 comprises a tubular membrane that is coupledto the upper member 10 and to the lower member 12. In selectembodiments, the upper member 10 and the lower member 12 are retentionrings. In other embodiments, the upper member 10 and the lower member 12are other retention devices such as adhesive straps. A fluid deliverymember 16 is coupled to the upper member 10 and a fluid conduit member18 is placeable in fluid communication with the fluid delivery member16. The fluid conduit member 18 can be a tube or catheter with one lumenor with multiple lumens. The fluid delivery member 16 can be a tube, atube with holes, a sponge, a porous medium, and/or another suitable itemthat can delivery fluid. The sheath 14 can be a pliable membrane, arigid membrane, or a tube of sufficient diameter to enable access to thesurgical site. In one embodiment, the sheath 14 is a plastic, conicaltube that is sufficiently rigid to expand the incision. In someembodiments, the fluid conduit member 18 is an inlet conduit member.

FIG. 3 illustrates how the surgical access device 8 a provides a paththrough the skin 2, subcutaneous fat 20, and muscle 22 to facilitateaccess to an organ 24 on which the physician needs to operate. Fluid canflow through the fluid conduit member 18 to the fluid delivery member16, which delivers the fluid to one or more parts of the surgical siteincluding, but not limited to, the skin 2, subcutaneous fat 20, muscle22, and organs 24. The fluid may be comprised of, but is not limited to,saline solution, water, antibiotic solution, solution containing a dye,solution containing radioactive particles, solution containingfluorescent particles, solution containing nanoparticles, solutioncontaining narcotic agents, solution containing analgesic agents,diagnostic agents, therapeutic agents, and/or solution containingimmunotherapeutic agents. Some embodiments irrigate with gels and/orpastes. Some embodiments deliver heated fluids that are above roomtemperature. For example, fluids may be heated using a Level 1® H-1200Fast Flow Fluid Warmer manufactured by Smiths Medical (Dublin, Ohio).Other embodiments deliver cold fluids that are below room temperature.

As is explained in greater detail below, surgical access devices cancomprise a tissue barrier such as a sheath, a flexible conduit, or apliable membrane. Tissue barriers can come in diverse shapes, sizes, andmaterials. In some embodiments, a purpose of a tissue barrier is to helpirrigate the surgical site by increasing the probability of theirrigating fluid, paste, gel, or substance of being in contact with thedesired portions of the surgical site. In some embodiments, a purpose ofthe tissue barrier is to help retract the tissue.

FIG. 4 illustrates an embodiment of a fluid irrigation system in theform of two rings connected by a flexible conduit comprising a pluralityof walls. The fluid delivery member 16 comprises a pliable membrane 34with perforations 36. The perforations 36 can be arranged in anysuitable manner. In one embodiment, the perforations 36 are evenlyspaced apart to irrigate the entire surgical site. In anotherembodiment, the perforations 36 are generally clustered towards thesecond retention ring 32 such that the fluid drips down the walls of thesurgical site. The perforations 36 make the pliable membrane 34 afluid-permeable material. Not all of the perforations 36 in FIG. 4 arelabeled in order to make the illustration less cluttered and easier tosee. The perforations 36 are illustrated as small, black dots in FIG. 4.The plurality of walls can be heat sealed together in select portions.

The pliable membrane 34 can be any tissue barrier that is at leastpartially flexible or is at least partially conformable under normaltissue retracting conditions. Pliable membranes 34 can come in manyshapes and thicknesses. In one embodiment, the pliable membrane 34 isone inch thick. In other embodiments, the pliable membrane 34 is lessthan 0.01 inch thick. In some embodiments, the pliable membrane 34 formsa tube. In other embodiments, the pliable membrane 34 is not tubular,but is shaped like a flat sheet.

In some embodiments, the pliable membrane 34 includes seals to preventbillowing of the structure. Preventing billowing helps provide reliableaccess to the surgical site.

In this embodiment, the surgical access device 8 b comprises a firstretention ring 30 that is coupled to a second retention ring 32 by aflexible conduit or pliable membrane 34. In the illustrated embodiment,the pliable membrane 34 is a tubular membrane, the first retention ring30 is circular, and the second retention ring 32 is circular. Tubularmembranes can have many cross sectional shapes including, but notlimited to, cross sections that are square, diamond, parallelogram,rectangular, triangular, pentagonal, hexagonal, and elliptical.

The second retention ring can be attached to a frame such as aBookwalter retractor made by Codman & Shurtleff, Inc. (a Johnson &Johnson company). Attaching the second retention ring to a frame canprovide the mechanical rigidity necessary in some embodiments to expandthe incision.

In some embodiments, the pliable membrane 34 includes at least twoperforations 36 or holes. The perforations may have many shapesincluding, but not limited to, round, triangular, and rectangular. Insome embodiments, the perforations are different sizes. For example, theperforations 36 located within one inch of the second retention ring 32may be 25 to 200% larger in cross-sectional area than the perforations36 located 1.5 to 10 inches from the second retention ring 32 to providea more even flow or to provide a biased flow. In one embodiment, thepliable membrane has at least ten perforations 36 but less than 125perforations 36. In another embodiment, the pliable membrane 34 has atleast 125 perforations 36 but less than 500 perforations 36. Theperforations may be located in a sinusoidal pattern, a zigzag pattern,or in a straight line.

The interior surface of the pliable membrane 34 permits access to thesurgical field with the hand or other instruments (e.g., robots,laparoscopic instruments, retractors, tissue sealing devices). Theillustrated embodiment comprises a fluid source 44, which may be a bagor container that holds a fluid. An inlet conduit 40 places at least aportion of the surgical access device 8 b in fluid communication withthe fluid source 44. The inlet conduit 40 may be an inlet tube. Anoutlet conduit 42 is in fluid communication with at least a portion ofthe surgical access device 8 b. The outlet conduit 42 may be an outlettube.

In one embodiment, the second retention ring 32 comprises an inletconduit such as a fluid delivery inlet 46. Gravity can typically drivethe fluid through the system, although some embodiments utilize a pumpor other pressure source. In one embodiment, an outlet conduit of thefirst retention ring 30 is in fluid communication with the inlet conduit40 via space formed between two generally concentric flexible walls.

FIG. 5 provides a cross-sectional view through the inlet conduit 40,pliable membrane 34, and second retention ring 32. Fluid 48 entering thesecond retention ring 32 by means of the inlet conduit 40 is directedbetween an inner wall 50 and an outer wall 52 of the pliable membrane34. The outer wall 52, which is configured to be in contact with tissuein the wound, comprises a plurality of perforations 36 configured todeliver at least a portion of the fluid 48 to the tissue in or near thesurgical site. In this manner, fluid, such as antibiotic fluid, salinesolution, or other fluid, is delivered to wound tissues. In variousembodiments, the perforations are less than 0.25 mm, between 0.15 mm and0.35 mm, between 0.25 mm and 0.50 mm, or between 0.5 mm and 1.5 mm. Thespace 62 between the inner wall 50 and the outer wall 52 enables fluidto pass between at least a portion of the inner wall 50 and the outerwall 52. Thus, the fluid can travel in the space 62 through at least aportion of the pliable membrane 34 before the fluid exits the surgicalaccess system. In one embodiment, the space 62 is filled with a porousmaterial and the inner wall 50 and the outer wall 52 are nonporousmaterials.

Select embodiments include a pliable membrane 34 with a coating. Inorder to enhance the ability of the surgical access device 8 c todeliver fluid to the surgical access site including, but not limited toskin 2, subcutaneous fat 20, muscle 22, and organs 24, the pliablemembrane 34 can be provided with a hydrophilic coating, such as theHydak® hydrophilic coating provided by Biocoat, Inc., to encourage fluiddispersion along its surface. The coating can be applied to one or bothsides of outer wall 52. The coating can also be applied to the innerwall 50. A coating on a surface that defines the boundary of the space62 can enhance fluid dispersion throughout the space 62. Enhanced fluiddispersion can increase the number of the perforations 36 through whichfluid flows to irrigate the surgical site. The coating on an outersurface of the outer wall 52 can enhance the fluid dispersion along theexterior of the surgical access device 8 c and, therefore, enhance thefluid delivery to the surgical access site.

In one embodiment, the fluid 48 has at least three flow stages. In afirst flow stage 54, the fluid 48 flows through the inlet conduit 48. Ina second flow stage 56, a least a portion of the fluid 48 flows betweenthe inner wall 50 and the outer wall 52. In a third flow stage 58, atleast a portion of the fluid 48 flows through the perforations 36 inroute to surgical site tissue. Another embodiment includes a fourth flowstage 60, in which at least a portion of the fluid 48 flows past theperforations 36 in route to more distally located perforations and/or toother features that are located closer than the perforations 36 to thefirst retention ring 30.

In another embodiment, the inlet conduit 40 is not in fluidcommunication with the second retention ring 32, but the inlet conduit40 is in fluid communication with the pliable membrane 34.

FIG. 6 provides a cross-sectional view through the pliable membrane 34and first retention ring 30. In an embodiment, the first retention ring30 comprises a hollow ring 64 and a fluid removal conduit 68 is in fluidcommunication with the hollow ring 64. The fluid removal conduit 68 maybe placed in fluid communication with the outlet conduit 42, which maybe connected to a medical suction device 72 (see FIG. 4), pump, orvacuum such that the outlet conduit 42 is a suction tube. The medicalsuction device 72 creates a pressure that is lower than atmosphericpressure to remove fluid from the surgical site. The fluid removalconduit 68 may be a tube, a channel, or any other suitable conduit.

The first retention ring 30 may include a ring opening 70 into which themedical suction device 72 may suck fluid 48 (not shown in FIG. 6) orbodily fluids from the surgical site. The first retention ring 30 may beconfigured to collect fluid from the wound for drainage purposes. Inanother embodiment, the pliable membrane 34 is configured to collectfluid from the wound for drainage purposes. For example, the pliablemembrane 34 may have pores or perforations that are in fluidcommunication with the medical suction device 72. Thus, the system canremove fluid by pulling the fluid into the pliable membrane and out theoutlet conduit 42.

In one embodiment, at least a portion of the inner wall 50 and at leasta portion of the outer wall 52 are fused together near the distal end ofthe pliable membrane 34. This embodiment may prevent direct fluid flowfrom the inlet conduit 40 to the outlet conduit 42 by forcing the fluid48 to flow out of the surgical access device 8 b before going back intothe surgical access device 8 b for removal from the patient's body.

In another embodiment, the fluid flow comprises two stages. In the flowexit stage 74, the fluid 48 exits the surgical access device 8 b andirrigates at least a portion of the surgical site. In the flow removalstage 76, the fluid 48 and bodily fluid are drawn into the surgicalaccess device 8 b, travel generally proximally in the fluid removalconduit 68, and are removed from the patient's body.

FIG. 7 illustrates how a surgical access device 8 c provides accessthrough skin 2 and subcutaneous fat 20 in route to a target site 80. Thetarget site 80 can be any site on which the physician desires tooperate. In this embodiment, the outlet conduit 42 is coupled to adistal portion of the surgical access device 8 c. The distal portion towhich the outlet conduit 42 is coupled may be the first retention ring30 or may be a distal portion of a sheath 82.

In an embodiment, the sheath 82 is a pliable membrane. In anotherembodiment, the sheath is not a pliable membrane. The fluid 48 (notshown) may enter the fluid delivery inlet 46, exit the sheath 82, andirrigate the wound. The surgical access device 8 c may irrigate anytissue, including but not limited to skin, subcutaneous tissue,subcutaneous fat, fascia, muscle, organs, or any other part of thepatient's body. After irrigating the wound, fluid collected in thesurgical site may be removed through the outlet conduit 42.

In another embodiment, the sheath 82 includes an inner wall 50 and anouter wall 52. In another embodiment, the sheath is made of a singlematerial such as a sponge. In various embodiments, the sponge materialis Rayon®, polyester, or cotton.

FIG. 8 illustrates an embodiment which comprises a third retention ring84. In one embodiment, the third retention ring 84 is coupled to thesheath 82 and is part of a surgical access device 8 d. In thisembodiment, the first retention ring 30 is used to remove fluid. Inanother embodiment, the third retention ring 84 is used to remove fluid.A tissue barrier 86 generally holds the incision 4 open to providesurgical access. The tissue barrier 86 may be plastic, rubber, metal, orany other suitable material. In one embodiment, the tissue barrier istitanium. In various embodiments, the tissue barrier ispolytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene(ePTFE), polyurethane, or medical-grade silicone.

Although FIG. 4 illustrates circular retention rings, retention ringscan be many diverse shapes. For example, FIGS. 9a-9d illustrate variousretention ring embodiments that can be coupled to pliable membranes,sheaths, and tissue barriers. The retention ring embodiments illustratedin FIGS. 9a-9d are examples of closed shapes. FIG. 9a illustrates astar-shaped retention ring 90. FIG. 9b illustrates a diamond-shapedretention ring 92. FIG. 9c illustrates a cross-shaped retention ring 94.FIG. 9d illustrates an elliptical retention ring 96. A surgical accesssystem can have retention rings with different shapes. For example, asurgical access system can have a circular retention ring and a squareretention ring. Any of the embodiments described herein may employ anyof the shapes in FIGS. 9a -9 d.

FIG. 10 illustrates a surgical access device 8 e wherein the fluiddelivery member 16 comprises a porous medium 100. The porous medium 100is an example of a fluid-permeable material. The porous medium 100 canbe any material with pores large enough that liquid water can passthrough the material with an input pressure equal to a one meter columnof water in normal atmospheric conditions at room temperature. Theporous medium 100 can also be any material through which liquid watercan be pumped. In various embodiments, the porous medium is a sponge. Inthe embodiment illustrated in FIG. 10, the pliable membrane comprises asheath 82 and a porous medium 100. The porous medium 100 is located onthe exterior of the surgical access device 8 e to enable the porousmedium 100 to touch tissue in the surgical site. The sheath 82 lines theinterior of a surgical access channel. In another embodiment, asubstantial portion of the pliable membrane consists of a porous mediumand the pliable membrane does not necessarily comprise a sheath oradditional tissue barrier.

Several embodiments of surgical access devices reduce SSI by irrigatingthe surgical site with a fluid that reduces infection. Irrigation can bedirected to the surgical site such that fluid contacts the tissue in away that makes an infection less likely.

Fluid 48 may flow to the surgical access device 8 e via the inletconduit 40, which may be in fluid communication with a fluid reservoirsuch as a bag or syringe that contains fluid. The inlet conduit 40 maybe a tube that is coupled to a fluid delivery inlet port 102. The inletport fluidly couples the inlet conduit 40 to the surgical access device8 e. In the embodiment illustrated in FIG. 10, the inlet conduit 40 isin fluid communication with a pliable membrane. The inlet port 102fluidly couples the inlet conduit 40 to the porous medium 100.

The outlet conduit 42 is in fluid communication with the porous membrane100 such that fluids flow from the surgical site into the porous medium100 and out of the patient through the outlet conduit 42, which may be arubber tube or a flexible plastic tube. In various embodiments, theinlet conduit 40 and the outlet conduit 42 are detachable from thesurgical access device 8 e.

As illustrated in FIG. 10, the pliable membrane comprises a tubularmembrane. The tubular membrane comprises an upper portion 104 and alower portion 106. The lower portion 106 is closer than the upperportion 104 to the first retention ring 30. A first fluid conduitmember, illustrated as inlet conduit 40, is in fluid communication withthe upper portion 104. A second fluid conduit member, illustrated asoutlet conduit 42, is in fluid communication with the lower portion 106.In one embodiment, the upper portion 104 is not in direct fluidcommunication with the lower portion 106 such that fluid from the firstfluid conduit cannot flow to the second fluid conduit without exitingthe surgical access device and then reentering the surgical accessdevice. The user forces the fluid out of the upper portion 104 into thesurgical site by applying sufficient pressure to the fluid such that thefluid flows out of the upper portion 104 and into the surgical site. Inmany embodiments, gravity provides sufficient pressure to cause thefluid to flow into the surgical site.

In another embodiment, the upper portion 104 is not in substantiallydirect fluid communication with the lower portion 106 such that themajority of fluid from the first fluid conduit cannot flow to the secondfluid conduit without exiting the surgical access device and thenreentering the surgical access device.

FIG. 11 illustrates an embodiment of a surgical access device 8 f. Aporous medium 100, such as a diffusion sponge or foam, prophylacticallydoses the subcutaneous tissue in antibiotic solution to defend againstmicrobial invasion both during surgery and after surgery. The porousmedium 100 can be open cell foam. Fluid may be fed into the surgicalaccess device 8 f via gravity. A circumferential infusion channel system112 is embedded within the porous medium to enable uniform perfusionrates. The channel system 112 may include multiple channels thattogether provide the necessary fluid pathways. For example, one channelmay wrap 180 degrees around the perimeter and another channel may wrapanother 180 degrees around the perimeter such that together the channelsform a system that wraps all the way around the perimeter. Acircumferential vacuum channel 114 is placed in fluid communication witha suction tube 110. The suction tube 110 is connected to medical suctionto remove fluid from the surgical site. In another embodiment, thesuction tube 110 is fluidly coupled to a surgical access device thatdoes not have a circumferential suction channel 114.

The circumferential suction channel 114 may be located proximally to thefirst retention ring 30 and distally to the circumferential infusionchannel system 112. This configuration allows gravity to generally pullfluid from the inlet conduit 40 to the suction tube 110. In variousembodiments, the fluid removal means is located near the distal end of asurgical access device to reduce instances of unwanted fluid pooling inthe surgical site.

In several embodiments, the fluid removal system is positioned in amanner that is highly effective at removing unwanted fluid, which canincrease surgical site visibility. Increasing surgical site visibilitycan improve patient outcomes by enabling more precise surgery and canreduce procedure times, which can lower the probability of SSI.

In another embodiment, a surgical access device comprises a firstretention ring, a second retention ring, and a porous medium thatextends between the first retention ring and the second retention ring.The porous medium is impregnated or soaked with chemical or biologicalmeans to prevent infection before the porous medium is inserted into thesurgical site.

FIG. 12 illustrates an embodiment in which the fluid delivery member 16is located near the proximal end of a surgical access device 8 g. Thisconfiguration uses gravity to distribute fluid down through the surgicalsite. For example, fluid that exits the fluid delivery member 16 in thesubcutaneous fat layer could drip down to a target site, such as anabdominal cavity. In one embodiment, the fluid delivery member 16 isconnected to the second retention ring 32. In another embodiment, thefluid delivery member 16 is integrated into the second retention ring32.

The fluid delivery member 16 in FIG. 12 is a circumferential fluiddispersion ring. A circumferential fluid dispersion ring may wrap arounda portion of the surgical access device 8 g and may be located on thesurgical access device 8 g such that is does not rely on gravity todistribute fluid to the surgical site.

FIG. 13 illustrates an embodiment in which the fluid delivery member 16is located near the distal end of a surgical access device 8 h. Thisembodiment can be used to remove fluid through the fluid delivery member16. For example, the inlet conduit 40 can be placed in fluidcommunication with the fluid delivery member 16 and a medical suctiondevice 72 (see FIG. 4). Thus, the medical suction device 72 can suckfluid from the surgical site into the fluid delivery member 16, throughthe inlet conduit 40, and out of the patient's body. In one embodiment,a surgical access device removes fluid from the surgical site, but doesnot irrigate the surgical site.

In various embodiments, the fluid delivery member 16 is placed within 10mm, 20 mm, 30 mm, or 50 mm of the distal end of the surgical accessdevice 8 h. The fluid delivery member 16 may be a foam or sponge. In oneembodiment, the fluid delivery member 16 is connected to the firstretention ring 30. In another embodiment, the fluid delivery member 16is integrated into the first retention ring 30.

FIG. 14 illustrates an embodiment in which the pliable membrane 34comprises a tubular membrane 120 and a routing tube 122 with at leastone lumen. The routing tube 122 is disposed in a spiral direction aroundthe tubular membrane 120. The tubular membrane 120 comprises a first end120 a and a second end 120 b. The first end 120 a is coupled to thefirst retention ring 30. The second end 120 b is coupled to the secondretention ring 32. The routing tube 122 may be adhesively bonded to thetubular membrane 120. In one embodiment, the routing tube 122 ischemically bonded to the tubular membrane 120.

In another embodiment, the routing tube 122 is disposed in a helicaldirection around the tubular membrane 120. For the purposes of thisapplication, spiral directions include helical directions.

The surgical access system 8 i illustrated in FIG. 14 comprises a wire124 disposed inside at least a portion of the routing tube. The surgicalaccess device 8 i may have an anchor 126 or point at which the wire 124is anchored to the surgical access device 8 i. The wire 124 is generallyslideably disposed inside the routing tube 122 except for at one or moreanchor points or attachment points. In one embodiment, the wire 124 isanchored near its distal end. Pulling on the proximal end of the wire124 imparts a straightening force on the generally curved routing tube122. Thus, pulling the wire causes the tissue to retract around theincision by increasing the rigidity of the tubular membrane 120. Thepliable membrane 34 may be a polyurethane sheath that acts as a barrierto tissue in the surgical site.

The routing tube 122 illustrated in FIG. 14 is permeable to enable thefluid 48 to exit the routing tube 122 and irrigate the wound. Therouting tube 122 may be permeable because it comprises perforations,which may include many different shapes such as holes 130, slits 132,and spiral slots 134. FIGS. 15a-15c illustrate embodiments of holes 130,slits 132, and spiral slots 134. Thus, the routing tube 122 is a type offluid-permeable tube. Other types of fluid-permeable tubes are notconfigured to enable a wire to be slideably disposed inside the tubes.

FIG. 16 illustrates the routing tube orientation angle 140, which helpsdefine the spiral direction in which the wire 124 wraps around thetubular membrane 120 relative to the longitudinal axis of the surgicalaccess device 8 i. The routing tube orientation angle 140 can be anyangle between 90 degrees and −90 degrees. In various embodiments, therouting tube orientation angle 140 is between 90 degrees and 60 degrees,between 70 degrees and 50 degrees, and between 35 degrees and 55degrees. Other embodiments include the negative versions of thepreviously described ranges.

FIG. 17 illustrates another embodiment with a routing tube orientationangle 140. In this embodiment, the tubular membrane 120 has asubstantially cylindrical shape.

FIG. 18 illustrates an embodiment wherein the pliable membrane 34includes irrigation tubing 144. The inlet conduit 40 is in fluidcommunication with the irrigation tubing 144 such that the fluid 48flows though the inlet conduit 40, into the irrigation tubing 144, andout into the surgical site. In various embodiments, the irrigation tubes144 are generally formed in an undulating pattern with portions that aregenerally vertical.

FIG. 19 illustrates an embodiment wherein the fluid delivery member 16comprises a tubing having a lumen 146 with holes 148. The lumen holes148 are configured to deliver fluid to the surgical site.

FIG. 19 also illustrates an embodiment that comprises a flow controllingmeans such as a flow regulator 150. A flow controlling means canoptionally be placed within the inlet flow system to limit the flow rateinto the surgical access device 8 k. A flow controlling means canoptionally be placed within the outlet flow system to limit the flowrate out of the surgical access device 8 k. Additionally, the flowcontrolling means can be integrated with a fluid conduit connector orintegrated into a portion of the surgical access device 8 k.

The flow regulator 150 can contain a means of regulating pressure and/orflow rate into the device. Optionally, the regulation means can be apressure-reducing element, such as a high flow resistance member.Optionally, the regulation means can establish a pressure threshold tosubstantially ensure sufficient pressure exists to establish the fluidflow. The regulation means can be comprised of a one-way valve with adefined cracking pressure, a flapper valve, or a duckbill valve.Additionally, the flow controlling means assembly can incorporate afeedback element indicating to the user when fluid is flowing throughthe device. For example, the flow controlling means can include aspinning turbine indicator.

FIGS. 20 and 21 illustrate another means to expand the incision tofacilitate access to a surgical site within a patient's body. Thesurgical access device 8L comprises a first retention ring 30, a secondretention ring 32, and a pliable membrane 34 extending between the firstretention ring 30 and the second retention ring 32. The pliable membrane34 is configured to expand the incision by inflating with a liquid or agas. The pliable membrane 34 comprises inflatable chambers 152, whichare selectively placeable in fluid communication with a fluid source.Inflating the inflatable chambers 152 pushes the surgical site in anoutward direction. Thus, the surgical access device 8L expands theincision.

A high-pressure fluid source 156 (as shown in FIG. 21) may be used toinflate the inflatable chambers 152. In one embodiment, the inflatablechambers 152 are inflated to 30 pounds per square inch. Inflation tubes158 place the high-pressure fluid source 156 in fluid communication withthe inflatable chambers 152. In one embodiment, at least some of theinflatable chambers 152 are approximately donut-shaped or hoop-shaped.In another embodiment, an inflatable chamber is helical or spherical. Inone embodiment, the high-pressure fluid source is a pressurized CO₂cartridge.

FIGS. 22-25 illustrate an expandable ring embodiment with at least tenlinkages. In some embodiments, surgical access devices with anexpandable ring enable wound irrigation, but do not expand the incisionto enable surgical access. In other embodiments, surgical access deviceswith an expandable ring do not enable wound irrigation, but expand theincision to enable surgical access. In other embodiments, surgicalaccess devices with an expandable ring enable wound irrigation andexpand the incision to enable surgical access.

The embodiment illustrated in FIGS. 22-25 comprises a first retentionring 30, an expandable ring 160, and a pliable membrane 34 extendingbetween the first retention ring 30 and the expandable retention ring160. FIG. 23 shows the expandable ring 160 in a collapsed configuration160 a. FIG. 24 shows the expandable ring 160 in an expandedconfiguration 160 b. Not all of the elements in FIG. 24 are labeled inorder to make the illustration less cluttered and easier to see. Forexample, not all of the pivots 164, which are represented by circles,are labeled. Some of the pivots 164 are hidden by linkages 162. Not allof the linkages 162 are labeled. The patient's skin 2 in FIGS. 23 and 24is indicated by cross hatching. A central channel 78 extends through thecenter of the pliable membrane 34 to provide access to the surgicalsite, which is target site 80 in FIG. 24.

Several embodiments of systems with expandable retention rings reducethe need to use different retractor sizes in a single surgical sitebecause the expandable retention ring can grow in diameter as theincision size increases. These embodiments sometimes eliminate the needto replace a first retractor with a second, larger retractor if theincision becomes larger.

The collapsed configuration 160 a is the configuration in which theexpandable ring 160 has the smallest inner diameter 170. Configurationswith an inner diameter 172 that is larger than the smallest innerdiameter 170 are expanded configurations. In one embodiment, the innerdiameter of the maximum expanded configuration is at least 50% largerthan the inner diameter of the collapsed configuration 160 a. In anotherembodiment, the inner diameter of the maximum expanded configuration isat least 100% larger than the inner diameter of the collapsedconfiguration 160 a. In yet another embodiment, the inner diameter ofthe maximum expanded configuration is at least 200% larger than theinner diameter of the collapsed configuration 160 a. In manyembodiments, there are many expanded configurations with inner diametersthat are smaller than the inner diameter of the maximum expandedconfiguration.

In the illustrated embodiment, the expandable ring 160 is configured toexpand from a collapsed configuration 160 a to an expanded configuration160 b. The expandable ring 160 is an example of an expandable retentionmember. The expandable retention ring 160 comprises at least fourlinkages 162 pivotably coupled to one another by pivots 162 such thatexpanding the expandable ring 160 causes the linkages 162 to pivotrelative to each other. In other embodiments, an expandable retentionmember comprises at least three linkages that may form in a “C” shape.

FIG. 24 shows the upper side of the expandable ring 160. FIG. 25 showsapproximately half of the lower side of the expandable ring 160. A pivot164 may be formed by a pin on one link that is pivotably located insidea cylindrical hole of another link. Both FIG. 24 and FIG. 25 show pivotembodiments, although other expandable ring 160 embodiments compriseother pivot styles, pivot locations, and pivot geometries.

The first retention ring 30 and the second retention ring 32 may be madefrom rubber. In the embodiment illustrated in FIG. 22, a first retentionring 30 a is made from 85 Shore A medical-grade rubber. This firstretention ring 30 a is deformable because a physician can squeeze thering's otherwise circular shape into an elliptical shape or into anothersuitable shape to squeeze the ring into the incision in a collapsedconfiguration. Once the ring is in the desired location inside thepatient's body, the physician can stop squeezing the ring to allow thering to at least partially return to its initial shape. In thisembodiment, the initial shape is circular. Thus, the ring would returnto a generally circular shape or to a generally elliptical shape. Aretention ring is deformable if a typical physician can substantiallydeform the retention ring to place the retention ring into an incisionwithout breaking the retention ring. In several embodiments, the firstretention ring 30 is not deformable.

In an embodiment, the second retention ring 32 is made from 50 Shore Dmedical-grade plastic. In this embodiment, the second retention ring 32is less flexible than the first retention ring 30 because the secondretention ring 32 does not have to collapse or deform to enter thepatient's body. In other embodiments, the second retention ring 32collapses and/or deforms.

In several embodiments, a pliable membrane is made from medical-gradesilicone rubber. In some embodiments, the pliable membrane comprises asilicone tube with an inner diameter large enough to enable aphysician's hand to pass through the inner diameter. In someembodiments, the pliable membrane may also include a plastic tube thatspirals around the silicone tube.

In other embodiments, the pliable membrane comprises polyethylene,polyurethane, or nylon. In one embodiment, the tubular membrane is madefrom polyethylene.

In any method or process disclosed herein, the acts or operations of themethod or process may be performed in any suitable sequence and are notnecessarily limited to any particular disclosed sequence. Moreover, themethods described herein include many optional steps and many optionalstep elements and portions. Many of the methods depicted in the Figuresinclude alternative steps. Thus, method embodiments often do not includeperforming each step depicted in the Figures, but rather often includeonly a subset of the depicted steps.

A method for retracting and providing fluid to tissue around an incisionin a body during surgery may involve advancing a first retention ringinto the body through the incision in a collapsed configuration andplacing a second retention ring outside the body. The second retentionring may be coupled to the first retention ring by a pliable membrane.The pliable membrane may be configured to retract the tissue around theincision. The method may further involve retracting the tissue aroundthe incision and introducing the fluid into a fluid delivery inletcoupled to the pliable membrane such that the fluid exits the pliablemembrane through at least one opening in the pliable membrane.

The method may additionally involve vacuuming or suctioning the fluidinto the pliable membrane and removing the fluid from the body.Alternatively or additionally, a fluid conduit member may be coupled tothe first retention ring and the method may involve vacuuming orsuctioning the fluid into the fluid conduit member and removing thefluid from the body. The fluid may comprise an antibiotic fluid, asaline solution, any suitable irrigation fluid, any medicating fluid, orany other therapeutic fluid.

The method may additionally involve expanding the second retention ringwhereby expanding the second retention ring causes the pliable membraneto retract the tissue around the incision. In select embodiments, thesecond retention ring comprises at least four linkages pivotably coupledto one another and expanding the second retention ring comprisespivoting the at least four linkages relative to each other.

In another embodiment, a wire is spirally or helically wound around thepliable membrane and retracting the tissue around the incision comprisespulling the wire. Pulling the wire alters the hoop strength of thepliable membrane, which retracts the tissue. In various configurations,pushing the wire increases the hoop strength, which retracts the tissue.In such cases, a wire is spirally or helically wound around the pliablemembrane and retracting the tissue around the incision comprises pushingthe wire.

In another embodiment, retracting the tissue around the incisioninvolves inflating at least a portion of the pliable membrane. In oneembodiment, inflatable air chambers inflate such that they becomedonut-shaped or such that they form a tube through which a physician caninsert her hand to reach the target site. Fluids such as water andsaline solution may be used to inflate the chambers. Gases may also beused to inflate the chambers. The membrane may be permeable to permitthe inflating material to exit the membrane and be delivered to thetissue.

FIG. 26 illustrates an alternative method embodiment. Step 202 mayinclude advancing a first retention ring into a body through anincision. Step 204 may involve placing a second retention ring outsidethe body. The second retention ring may be coupled to the firstretention ring by a tissue barrier. The surgical access device maycomprise the first retention ring, the second retention ring, and thetissue barrier. Step 206 may involve retracting the incision using atleast a portion of the surgical access device. Step 208 may includeintroducing fluid into a fluid delivery inlet fluidly coupled to thesurgical access device such that the fluid exits the surgical accessdevice. Step 210 may include irrigating at least a portion of a surgicalsite with the fluid.

Several other embodiments do not include irrigation or fluid removal.For example, FIG. 27 illustrates an alternative method embodiment. Asshown in Step 220, the method may include advancing a first retentionring into a body through an incision. As shown in Step 222, the methodmay also include placing a second retention ring outside the body. Thesecond retention ring may be coupled to the first retention ring by apliable membrane, a tubular member, a conical member, and/or by a tissuebarrier. As shown in Step 224, the method may also include expanding thesecond retention ring, whereby expanding the second retention ringcauses the pliable membrane to retract tissue around the incision. Asshown in Step 226, the second retention ring may comprise at least fourlinkages. Expanding the second retention ring may comprise pivoting theat least four linkages relative to each other. In another embodiment,the second retention ring has at least three pivoting linkages. In yetanother embodiment, the second retention ring has at least ten pivotinglinkages. In yet another embodiment, the second retention ring has atleast nineteen pivoting linkages.

FIG. 28 illustrates many different method steps that may apply tovarious embodiments. Step 230 may include advancing a first retentionring into a body through an incision. Advancing the first retention ringthrough an incision may involve collapsing or deforming the firstretention ring to enable the first retention ring to enter the incision.Step 232 may include placing a second retention ring outside the body.The second retention ring may be coupled to the first retention ring bya pliable membrane. The pliable membrane may be configured to retracttissue around the incision.

Step 234 may include retracting the tissue around the incision. Step 236may include expanding the second retention ring, whereby expanding thesecond retention ring causes the pliable membrane to retract the tissuearound the incision. The second retention ring may comprise at leastfour linkages, at least ten linkages, or at least nineteen linkages.Step 240 may include pivoting the linkages relative to each other toexpand the second retention ring. Step 242 may include retracting thetissue around the incision by pulling a wire or by pushing a wire. Thewire may be spirally or helically wound around the pliable membrane.Step 244 may include retracting the tissue around the incision byinflating at least a portion of the pliable membrane to expand the outerdiameter of the pliable membrane to push the tissue out of the way andto create an access channel through which the physician can insert ahand.

Step 246 may include introducing fluid into a fluid delivery inletcoupled to the pliable membrane such that the fluid exits the pliablemembrane through at least one opening in the pliable membrane. Otherembodiments include at least six openings in the pliable membrane.

Step 250 may include vacuuming or suctioning at least a portion of thefluid into the pliable membrane or into another part of the surgicalaccess device. Another embodiment includes vacuuming or suctioning atleast a portion of the fluid into the first retention ring. Yet anotherembodiment includes vacuuming or suctioning at least a portion of thefluid into the second retention ring.

Step 252 may include vacuuming or suctioning at least a portion of thefluid into a fluid conduit member that is coupled to a surgical accessdevice. The surgical access device may comprise the first retentionring, the second retention ring, and the pliable membrane.

Step 254 may include removing at least a portion of the fluid from thepatient's body. For example, at least a portion of the irrigatingsolution and additional bodily fluid, such as blood, may be removed fromthe patient's body.

FIG. 29 illustrates various manufacturing and/or assembly steps thatapply to various embodiments. Step 260 may include constructing a firstretention ring. Step 262 may include constructing a second retentionring. Step 264 may include coupling the first retention ring to thesecond retention ring using a pliable membrane. In at least oneembodiment, one end of a pliable membrane is coupled to a firstretention ring and a second end of the pliable membrane is coupled to asecond retention ring. In other embodiments, a retention ring is coupledto a portion of the pliable membrane that is between the first end andthe second end.

Step 266 may include coupling a fluid delivery conduit to the pliablemembrane such that the fluid delivery conduit is capable of fluidcommunication with the pliable membrane. Step 270 may include fluidlycoupling a fluid delivery conduit to the first retention ring such thatthe fluid delivery conduit is capable of fluid communication with thefirst retention ring. Step 272 may include fluidly coupling a fluiddelivery conduit to the second retention ring such that the fluiddelivery conduit is capable of fluid communication with the secondretention ring.

Step 274 may include coupling a fluid removal conduit to the pliablemembrane such that the fluid removal conduit is capable of removingfluid from the pliable membrane. Step 276 may include coupling a fluidremoval conduit to the first retention ring such that the fluid removalconduit is capable of removing fluid from the first retention ring. Step280 may include coupling a vacuum or suction device to the fluid removalconduit. Step 282 may include coupling a fluid source to the fluiddelivery conduit.

FIGS. 24 and 25 illustrate an expandable ring embodiment that comprisespivots 164, which pivotably couple linkages 162. Other expandable ring160 embodiments comprise other pivot styles, pivot locations, and pivotgeometries. In several embodiments, expandable rings do not use pivots,but instead use living hinges. Living hinges may pivotably couplelinkages.

In one embodiment, a second retention ring is configured to expand froma collapsed configuration to an expanded configuration. The secondretention ring comprises at least four linkages pivotably coupled to oneanother by living hinges such that expanding the second retention ringcauses the linkages to pivot relative to each other. In severalembodiments, a first retention ring is configured to expand from acollapsed configuration to an expanded configuration. The firstretention ring comprises at least four linkages pivotably coupled to oneanother by living hinges such that expanding the second retention ringcauses the linkages to pivot relative to each other.

In at least one embodiment, two sets of linkage chains having livinghinges connecting each link are connected to each other by a pinnedpivot joint. In one embodiment, a living hinge is made by a section ofmaterial that is thinner and more flexible than the adjoining sectionsof material that the living hinge connects.

FIG. 30a illustrates a section of an expandable ring embodiment withliving hinges 300 and pivots 164. In this embodiment, both the livinghinges 300 and the pivots 164 help to pivotably couple the linkages 162.The linkages 162 are coupled by living hinges 300 instead of beingcoupled solely by hinges comprising of one or more parts rotating abouta bearing surface. One example of a bearing-surface, pivot design is apart rotating about a pin. The bearing surfaces may be the innerdiameter of a cylindrical hole and the outer diameter of a pin.Bearing-surface pivots may be referred to as bearing surface hinges,pinned hinges, or pin joints. Potential advantages of living hinges mayinclude reduced part count, less assembly complexity, and improveddurability.

In the embodiment illustrated in FIG. 30a , each linkage subassembly isformed in a generally “zig-zag” shape. In other words, in severalembodiments, the shape substantially shortens its overall length whenits linkages 162 are brought together by bending the living hinges 300that join the linkages 162 of the subassembly. The bending of the livinghinges 300 enables the linkages 162 to pivot relative to each other.This pivoting action is permitted by a region of substantially thinnermaterial in the bending area. In one embodiment, the material used tocreate the linkages 162 has high fatigue resistance. Several embodimentsuse polypropylene, polyethylene, or another suitable polyolefin. Otherpolymers may be used, and in some embodiments, metals may be used.

The two linkage subassemblies can be pivotably joined by a pinned hingejoint or other suitable non-living hinge joint to enable the expandingring design described previously. In FIG. 30a , the subassemblies arepivotably joined by pivots 164.

Various embodiments utilize injection molding, die cutting, water-jetcutting, wire electrical discharge machining, laser cutting, and etchingto manufacture the linkages. In one embodiment, an expandable ring ismanufactured by over-molding in a single-shot mold, with pin-hingeelements molded in place.

FIG. 30b illustrates a section of an expandable ring embodiment whereinall of the pivoting sections are living hinges 300 rather thantraditional pin pivots. In this embodiment, living hinges 300 pivotablycouple the linkages 162. Cylindrical hinges 302 couple intersectinglinkages 162. Cylindrical hinges 302 are another type of living hingethat are essentially cylindrical columns of the material used to moldthe linkages 162. The cylindrical hinges 302 twist to enable thelinkages 162 to pivot relative to each other. In this embodiment, theentire expandable ring may be molded as a single piece.

In various embodiments, the linkages of an expandable ring havedifferent lengths and are oriented relative to each other at differentangles. This approach enables noncircular and/or nonsymmetricalcollapsed and expanded shapes. Noncircular shapes can be advantageous tobetter match the geometry of an expanded incision than is possible witha circular shape.

Expandable rings may have many different types of shapes including theshapes illustrated in FIGS. 9a-9d . For example, an expandable ring mayhave an elliptical shape as shown in FIG. 9d . The curvature of anelliptical expandable ring is greater near an end of the major axis thannear the near an end of the minor axis. Curvature can be controlled byadjusting the link angle of individual linkages, where the link angle isdefined as the angle between a line connecting a first pivot disposed ata first end of the linkage and a second pivot disposed at asubstantially central portion of the linkage and a line connecting athird pivot disposed at a second end of the linkage and the secondpivot. Greater curvature can be achieved by decreasing the link angle ofthe pivotably coupled links. Lesser curvature can be achieved byincreasing the link angle of the pivotably coupled links. In otherwords, the link angles near an end of the major axis are smaller thanlink angles near an end of the minor axis. In one embodiment, the linkangle of the pivotably coupled links at an end of the major axis are 150degrees, while the link angle of the pivotably coupled links at an endof the minor axis are 165 degrees.

FIG. 31a illustrates an expandable ring 160 in a completely expandedconfiguration. FIG. 31b illustrates the expandable ring 160 from FIG.31a in a completely collapsed configuration. Not all of the elements inFIG. 31b are labeled in order to make the illustration less clutteredand easier to see. For example, not all of the pivots 164, which arerepresented by small circles, are labeled. The expandable ring 160illustrated in FIGS. 31a and 31b is elliptical. The angle betweenadjacent linkages 162 is called the link angle. The lengths of thelinkages 162 and the link angles play an important role in determiningthe shape of the expandable ring 160. Using different lengths and linkangles enable many diverse expandable ring shapes including shapes thatare generally circular, elliptical, rectangular, and triangular.

Differing regions of curvature can be achieved by incorporatingdifferent link angles. As illustrated in FIG. 31b , link angles 166 and168 are generally smaller in regions of greater curvature (e.g., nearthe major axis of an elliptical shape) than in regions of lessercurvature (e.g., near the minor axis of an elliptical shape).

Maintaining an expanded configuration is often desirable to facilitatesurgery as well as to deliver a therapeutic fluid. In general, akinematic property of several of the expandable ring embodimentsdisclosed previously is that constraining the relative position of any 2links or pivots is sufficient to constrain the shape of the expandablering structure. This property arises from the linkages being coupledtogether in an expandable, interrelated manner.

The retention ring may comprise ratchet teeth configured to selectivelymaintain an expanded configuration. The retention ring may also compriseat least one ratchet pawl configured to selectively maintain theexpanded configuration by engaging at least a portion of the ratchetteeth. The surgical access device may also comprise a release memberconfigured to disengage the ratchet pawl from the ratchet teeth toenable the retention ring to return to the collapsed configuration. Inselect embodiments, the surgical access device comprises a userinterface button coupled to at least one of the ratchet teeth and/or tothe ratchet pawl. The user interface button is configured to disengagethe ratchet pawl from the ratchet teeth to enable the retention ring toreturn to the collapsed configuration. In at least one embodiment, thesurgical access device comprises a locking mechanism. The lockingmechanism is configured to selectively lock the second retention ring inan expanded configuration. The locking mechanism can comprise aprotrusion and an indentation. The protrusion is configured to engagethe indentation to selectively lock the retention ring in the expandedconfiguration.

FIG. 32 illustrates an expandable ring 160 embodiment with a lockingmechanism 310. The illustrated locking mechanism 310 is constrainedbetween two pivots. The locking mechanism is rotatably attached to onepivot. The locking mechanism 310 has teeth, which may be ratchet teeth312. One or more ratchet teeth 312 couple to a protrusion 314 (such as apin or a protuberance) on a second pivot or on a linkage. In at leastone embodiment, the protrusion 314 is a ratchet pawl configured toselectively maintain an expanded configuration by engaging at least aportion of the ratchet teeth 312. The valleys between the teeth 312 areindentations 316. The protrusion 314 is configured to engage at leastone indentation 316 to selectively lock the expandable ring 160 in anexpanded configuration. Note that placing the protrusion 314 in adifferent indentation 316 enables different expandable configurations,which have different diameters. Thus, the illustrated embodiment isconfigured to selectively maintain various expanded configurations.

A release mechanism 320 is configured to disengage the protrusion 314from the ratchet teeth 312 to enable the expandable ring 160 to returnto a collapsed configuration. Pressing on the release mechanism 320 in adirection that is transverse to the longitudinal axis of the lockingmechanism 310 pushes the protrusion 314 out of the indentation 316 andaway from the ratchet teeth 312. As a result, the locking mechanism 310no longer constrains the distance between the two pivots and theexpandable ring 160 is free to change in diameter.

Other embodiments involve other means of constraining the relativemovement of two linkages. In at least one embodiment, an expandablering's diameter is locked by constraining relative movement between ajoint and a linkage. In yet other embodiments, multiple lockingmechanisms are used on one expandable ring to reduce the system'sdependence on the interrelatedness of the linkages. This approachenables less rigid components to provide sufficient overall rigidity. Inone embodiment, the linkages are molded from medical-gradepolyetheretherketone (PEEK). In some embodiments, the linkages aremachined from a metal such as stainless steel to provide sufficientrigidity and to enable repeated autoclave sterilization.

Referring now to FIGS. 32 and 33, locking mechanism 310 may be coupledto one pivot with a torsion spring pin 322 to push the teeth 312 towardsthe protrusion 314. Thus, the torsion spring 328 biases the lockingmechanism 310 towards the protrusion 314, which may be on a pivot. Theteeth 312 illustrated in FIG. 32 are slanted such that the protrusion314 readily slips out of the indentations 316 when the expandable ring160 is expanding, yet the teeth 312 prevent the protrusion 314 fromslipping out of the indentations 316 when external forces attempt tocollapse the expandable ring 160. Thus, the expandable ring 160 resistscompressive forces but allows expansive forces to expand the expandablering 160. FIG. 33 illustrates a cross-sectional view of the torsionspring 328 and the torsion spring pin 322.

Another embodiment includes a first magnet disposed at the non-pinnedend of the locking mechanism 310 and a second magnet disposed near theprotrusion 314. The magnets provide the biasing force described above.Although the embodiments illustrated in various figures show the lockingmechanism 310 rotatably pinned near the inner diameter of the expandablering 160, the locking mechanism 310 in other embodiments is rotatablypinned near the outer diameter of the expandable ring 160.

In another embodiment, the locking mechanism is a piston-cylinderapparatus. A check valve prevents fluid from entering the cylinder,which resists tensile forces. This system can be configured to notresist expansion forces to enable easy expansion of the ring structureto cause incision expansion. Alternatively, a valve can be added toselectively resist further expansion. To release the constraint, thevalve can be opened, permitting free expansion and collapse. In anotherembodiment, a rotating latch attached to one pivot, releasably engagesanother pin by virtue of teeth formed to latch with the pivot. In yetanother embodiment, a caulk-gun-style mechanism is employed as thereleasable locking mechanism. In this embodiment, the mechanism hashigher friction in one direction than in the other direction. Thecaulk-gun-style mechanism is released by actuating the spring-biased tabor “garage” engaged against the sliding element.

In yet another embodiment, the releasable locking mechanism is a cable,wire, or string that substantially resists tension maintained by a clampmechanism disposed between one or more pivot points. The tensionresisting capability is released by pressing a button on the clampmechanism, thereby removing the clamping force.

Although several embodiments include a bar-like latch, other embodimentsutilize dramatically different locking mechanisms. For example, theembodiment illustrated in FIG. 34 has a pivot lock 324, which limits therotation of a first link 162 a and a second link 162 b about theirconnecting pivot. This single pivot lock 324 can lock the diameter ofthe entire expandable ring. Other embodiments include multiple pivotlocks 324. The pivot lock 324 includes a user interface button 326. Inone embodiment, the pivot lock 324 enables expansion of the expandablering 160 but prevents collapse of the expandable ring 160. Pressing theuser interface button 326 releases the pivot lock 324 to enable theexpandable ring 160 to return to the collapsed configuration 160 a. Inone embodiment, a pivot lock is constructed through the use of adeformable plug, which increases the rotational friction between links,and thus, constrains the structure's shape. In another embodiment, arotational ratcheting mechanism is disposed upon the pivot. Therotational ratcheting mechanism has locking teeth engaged in a positionto maintain the expandable ring's shape. Pressing a button releases thelocking teeth to enable collapsing the ring.

FIG. 35 illustrates cross section 35 from FIG. 34. In FIG. 35, the firstlinkage 162 a, the second linkage 162 b, and the rotational ratchet pawl330 are shown as cross sections to make the other portions of FIG. 35visible. (The other portions of FIG. 35 are not shown as crosssections.) The first linkage 162 a comprises a rotational ratchet pawl330. The user interface button 326 comprises rotational ratchet teeth332 and a reduced diameter zone 334. A spring 336 pushes the userinterface button 326 upward to the maximum height of the user interfacebutton 326. When the user interface button 326 is at its maximum height,the rotational ratchet teeth 332 engage the rotational ratchet pawl 330.When the user interface button 326 is pressed downward, the rotationalratchet teeth 332 disengage the rotational ratchet pawl 330 and therotational ratchet pawl 330 enters the reduced diameter zone 334, whichallows the first linkage 162 a to rotate freely relative to the secondlinkage 162 b. In one embodiment, the user interface button 326 iscoupled to the second linkage 162 b such that they cannot rotaterelative to each other. In another embodiment, the user interface button326 is coupled to the second linkage 162 b such that such that theycannot rotate relative to each other in one direction, but can rotaterelative to each other in the opposite direction.

FIG. 36 illustrates yet another embodiment. The tissue surrounding thesurgical access device places a compressive force on the expandable ringthat pushes the expandable ring towards a collapsed position. Thetorsion spring assembly 340 resists the tissue's compressive force. Therotational force of the torsion spring assembly 340 tends to expand theexpandable ring. In practice, the expandable ring naturally goes to itsmost expanded diameter unless another force resists the torsion springassembly 340. The physician compresses the expandable ring to facilitateplacing the surgical access device into the incision. Once the physicianreleases the compressive force that she is applying with her hands, thetorsional spring assembly 340 causes the expandable ring to expandtowards its most expanded diameter while the tissue of the surgical siteapplies a compressive force. The expansion force of the torsional springassembly 340 and the compressive force of the tissue reach equilibrium,which typically enables a large enough opening through the surgicalaccess device for the physician to access target tissue.

Some embodiments include multiple torsion spring assemblies 340. Oneembodiment has torsion spring assemblies 340 at each pivot of theexpandable ring 160.

In another embodiment, the expandable ring 160 has two or more discretestable configurations. In one embodiment, one stable configuration is asubstantially collapsed configuration and another stable configurationis an expanded configuration. Such behavior can be implemented using abistable or over-center mechanism, in which the lowest energyconfiguration corresponds to these two (or more) desired configurations.

FIGS. 37 and 38 illustrate a portion of an expandable ring 160. In anembodiment with multiple, stable configurations, an elastic member 350(rubber band, spring, etc.) is disposed about three pivots 164, wheretwo anchor pivots 164 a are connected to a primary linkage 162 a and athird pivot 164 b is connected to a secondary linkage 162 d. In oneembodiment, each end of the elastic member 350 is anchored to a pointsuch as an anchor pivot 164 a and the elastic member 350 stretches abouta pivot 164 b located along the length of the elastic member 350 betweenthe ends of the elastic member 350 that are anchored as illustrated inFIGS. 37 and 38.

FIG. 37 illustrates a partially expanded configuration. FIG. 38illustrates a fully expanded configuration. Note how the overall length(and therefore the stored energy) of the elastic member 350 passesthrough a maximum as the device is extended, leaving two low-energygeometric configurations that correspond to the desired configurationsof the expandable ring 160.

FIGS. 39-40 illustrate an embodiment of a second retention member 360a,b configured to expand from a collapsed configuration 360 a to anexpanded configuration 360 b. The second retention member 360 a,bcomprises at least three linkages 162 pivotably coupled to one anotherby pivots 164 such that expanding the second retention member 360 a,bcauses the linkages 162 to pivot relative to each other. The embodimentillustrated in FIGS. 39-40 is an open shape and is an example of a “C”shape. Some “C” shaped embodiments include curved linkages that may forma shape that is closed in a collapsed configuration and open in anexpanded configuration. Other embodiments of retention members includeretention rings of diverse shapes including the closed shapesillustrated in FIGS. 9a-9d . Yet other retention member embodimentsinclude retention frames. The second retention member 360 a,billustrated in FIGS. 39-40 is an example of a retention frame, althoughother second retention member embodiments are not retention frames.

FIG. 41 illustrates an embodiment wherein two retention members 400expand an incision 4 to facilitate access to a target site 80. Theretention members 400 are coupled by a connector 450. The illustratedconnector 450 and retention members 400 are stainless steel to providerigidity and reusability. A fluid delivery member 416 is coupled to eachretention member 400. Each fluid delivery member 416 has openings 454 toallow fluid (not shown) to exit the surgical access system 456 toirrigate the surgical site. The illustrated fluid delivery members 416are made from silicone, are disposable, and clip to the retentionmembers 400. The “C” shaped clips 452 are welded to the retentionmembers 400 and are sized to receive the fluid delivery members 416.Each fluid delivery member 416 is coupled to a fluid delivery tube 426or to another means of delivering fluid via a fluid delivery inlet 446.Fluid can flow though the fluid delivery tubes 426, through the fluiddelivery inlets 446, through the fluid delivery members 416, out of theopenings 454, and into the target site 80. Other embodiments includemore than two retention members 400 and components that are shapeddifferently than illustrated in FIG. 41.

The surgical access system 456 embodiment illustrated in FIG. 41 canalso include a fluid removal member 458 that is in fluid communicationwith a medical suction device 72. The fluid removal member 458 can be asilicone tube that is coupled to the surgical access system 456 by a “C”shaped clip 452. The fluid removal member 458 is configured to removefluid from the surgical site.

In one embodiment, the surgical access system 456 does not have means toirrigate the surgical site but does have means to remove fluid from thesurgical site. An example embodiment does not include fluid deliverymembers 416 but does include at least one fluid removal member 458. Inseveral embodiments, connecting a surgical access device to a rigidframe or to a structure rigidly connected to another rigid structure,such as a surgical bed, may be advantageous. Connecting a surgicalaccess device to a rigid structure can assist the surgeon in moving thesurgical field access to a different location to provide easier accessto different body tissues that need to be manipulated during surgery. Asdescribed above, the surgical device can be locked into a rigidstructure that may be free to move to different locations or may befixed in one location by attaching the rigid structure to a rigidadaptor configured to connect the locked device to a frame. In someembodiments, the frame is part of the surgical bed such that thesurgical access device can be immobilized relative to the surgical bed.

As shown in FIG. 42, an exemplary embodiment of this approach is anadaptor member 470 that connects to two of the pivots 164 a,b of thesurgical access device 8 m (shown in FIG. 22). The two engagementfeatures on the adaptor member 470 are a hole 472 and a slot 474. Thehole 472 engages a first pivot 164 b and the slot 474 engages a secondpivot 164 a. In this embodiment, the surgical access device 8 m can lockin a plurality of expanded configurations. Thus, the distance betweenthe first pivot 164 b and second pivot 164 a can change. Therefore, theslot 474 allows the adaptor member 470 to engage the second pivot 164 aregardless of varying expanded configurations. In one embodiment, thehole 472 for the first pivot 164 b is used to constrain the device intranslation, and slot 474 configured for the second pivot 164 a is usedto constrain the surgical access device 8 m in rotation about said firstpivot 164 b.

As shown in FIG. 43, the interface between adaptor member 470 and pivots164 can include a radial protrusion 482 on pivot post 480 and anindentation 484 on the adaptor member 470 to constrain the adaptermember 470 to the pivots 164 as well as facilitate simple assembly anddisassembly when needed during a surgical procedure. In someembodiments, this engagement means is additionally beneficial becausethe surgical access device 8 m may need to be selectively anchored indifferent locations with different pivots 164 throughout a case.

The entire contents of U.S. Pat. No. 4,254,763, entitled SURGICALRETRACTOR ASSEMBLY, and filed Jun. 7, 1979 are incorporated herein byreference. A rigid frame, such as shown in U.S. Pat. No. 4,254,763, canbe a surgical device that is rigidly attached to a surgical bed toprovide a plurality of attachment surfaces and locations for varioussurgical retractors used within a surgery. The retractor allows asurgeon to easily attach and remove retraction members using a ratchetpawl member that connects the retractor to the frame.

Referring now to FIGS. 6-7 of U.S. Pat. No. 4,254,763, one embodiment ofa ratchet pawl member is shown as element 72. The ratchet pawl member 72can have an opening 78 for accepting a member with ratchet teeth and aspring-loaded ratchet pawl 79 for engaging said ratchet teeth toselectively maintain the relative location of the two members.

Referring now to FIG. 42 in this document, the end opposite the pivotengagement hole 472 and slot 474 can include a post 476 and ratchetteeth 478 configured for acceptance into ratchet pawl member 72 (shownin U.S. Pat. No. 4,254,763).

In surgical use, adapter member 470 can be attached to the surgicalaccess device 8 m as described above and then positioned as desiredrelative to the surgical incision. A ratchet pawl member can then beattached to a rigidly fixed retractor such as a Bookwalter retractor.Post 476 on adapter member 470 can then be placed within the opening ofa ratchet pawl member to engage the ratchet pawl and ratchet teeth. Thepost 476 can be moved relative to the ratchet pawl member until thesurgical access device, and therefore, the surgical field access, is inthe desired location.

Referring now to FIGS. 44-45, in some embodiments, the surgical accessdevice 8 c can contain a sheath 82 that comprises channels 490 todeliver fluid to a surgical site. The channels 490 illustrated in FIGS.44-45 are external channels, although some embodiments include internalchannels. Sheath 82 can be a unitary structure, such as a film or sheet,with one or more external-facing channels 490. In some embodiments, thesheath 82 is a non-unitary structure. Channels 490 can deliver fluidalong their length and expose the abutting surgical site tissue tofluid. This embodiment can expose a significant surface area of thesurgical site to a fluid. The channels 490 can be disposed at any angle.Other embodiments include hundreds of channels. Several embodimentsinclude channels that intersect with each other to further enhance fluiddelivery. The depth of a channel 490 can be configured so as to maintaina patent channel even with retraction forces applied to the sheath 82.Various embodiments include channels that are 0 to 0.1 inches deep, 0.1to 0.35 inches deep, and 0.2 to 0.5 inches deep. Several embodimentsinclude channels having different depths or channels of varying depths.Channels 490 can be embossed onto sheath 82 using manufacturingprocesses such as hot embossing or thermoforming. Not all channels 490are labeled in FIGS. 44-45 to make the Figures easier to see. Thechannels 490 illustrated in FIGS. 44-45 have similar shapes, althoughother embodiments comprise channels with different shapes.

Referring now to FIGS. 46-47, a sheath 82 can comprise an inner layer 50and an outer layer 52. The outer layer 52 can comprise a plurality ofperforations 36. Several embodiments include 25 to 2,000 perforations.The inner layer 50 and the outer layer 52 can be joined to each other indistinct locations 492 to prevent the layers from separating from eachother in the joined areas. This separation can cause the inner layer 50to deflect into central channel 78 of the device and reduce the crosssectional area of channel 78. The joined locations 492 can be created byheat sealing, radio frequency welding, ultrasonic welding, or by usingan adhesive to join the inner layer 50 and the outer layer 52. Joinedlocations 492 can be linear, curved, or of any advantageous profile toreduce the ability of the sheath to separate. Joined locations 492 canbe comprised of a repeated pattern of one or more joined area shapes.Joined locations 492 can be different lengths and widths. Joinedlocations 492 can be seals.

The inner layer 50 and the outer layer 52 illustrated in FIG. 46 arequilted together. Quilted together means that the inner layer 50 and theouter layer 52 are joined at over three locations disposed between thedistal and proximal ends of the sheath 82. In several embodiments, theinner layer 50 and the outer layer 52 are joined at 3 to 10 locations,10 to 20 locations, 20 to 200 locations, and over 200 locations. Thejoined locations 492 can be spaced at regular or irregular intervals.Not all joined locations 492 and perforations 36 are labeled in FIGS.46-47 to make the Figures easier to see. The joined locations 492 areillustrated as rectangles, although other joined location 492 shapes areused in other embodiments. Perforations 36 are depicted as circles,although other perforation 36 shapes are used in other embodiments.

Referring now to FIGS. 48-49, joined lengths 494 can be used to isolateone or more perforations from one or more other perforations. The joinedlengths 494 can define chambers 496 in which fluid can pass within butcannot pass beyond. In other words, several embodiments include chambers496 that are sealed from one another such that fluid cannot pass fromone sealed chamber to another sealed chamber without exiting theperforations 36. Additional joined locations 492 can be included toprevent separation of the inner layer 50 and outer layer 52 within thechambers 496. Chambers 496 can be oriented in a direction substantiallyperpendicular to or parallel to or oblique to the axis of the centralchannel 78 of the surgical access device 8 c. In one embodiment, inletconduit 40 is a tube with holes 130 (see FIG. 15) along the tube'sentire distal end or along a portion of the distal end. Inlet conduit 40can be configured such that it passes through each chamber 496 to supplyfluid to each chamber such that the inlet conduit 40 is in fluidcommunication with each chamber 496. In several embodiments, one or moreholes 130 of the inlet conduit 40 are in fluid communication with eachchamber 496 such that fluid can generally reach each perforation 36.

As shown in FIG. 50, a compressible member 498, such as a piece of foamor other porous material or non-porous material, can be disposed withinchambers 496 to maintain patency under a compressive force such as thosepresent during surgical retraction. The compressible member 498 can helphold a chamber 496 open to facilitate fluid flow, which may have thepurpose of irrigation or fluid removal. Other embodiments include atleast one compressible member 498 in each chamber 496. In severalembodiments, member 498 is an incompressible member configured to propopen a chamber 496. The member 498 is illustrated with dashed linesbecause it is located inside the sheath 82. In other embodiments, themember 498 is located outside of the sheath 82.

As illustrated in FIG. 51, flow to each chamber 496 defined by joinedlengths 494 can be controlled to selectively deliver fluid to one ormore perforations 36 in the sheath 82. In several embodiments, thisconfiguration is advantageous to selectively deliver fluid toperforations 36 that substantially contact the surgical site. In oneembodiment, fluid delivery member 40 can comprise a plurality of tubes500 whose distal ends are in fluid communication with different chambers496. The chambers 496 can be oriented in a direction substantiallyperpendicular to or parallel to or oblique to the axis of the centralchannel 78 of the surgical access device 8 c. The tubes 500 can beconnected to a manifold 502 with a series of valves 504, such as needlevalves or gate valves, that control flow to one or more tubes 500. Insome embodiments, a surgeon can, at the time of operation, open one ormore valves 504 to deliver fluid to one or more tubes 500 and,therefore, to one or more chambers 496 and perforations 36. Thus, thesurgeon can deliver fluid to some perforations 36 while not deliveringfluid to other perforations 36.

As illustrated in FIG. 52, chambers 496 defined by joined lengths 494can additionally be used to apply suction to the surgical access device8 c and to remove fluid from the surgical site through perforations 36.An outlet conduit 68 can be connected to a medical suction device 72(see FIG. 4) on a proximal end (not shown) and a manifold 502 on adistal end. The manifold 502 can comprise one or more valves 504connected to tubes 500 to selectively apply suction to one or morechambers 496. The surgeon can, at the time of operation, open one ormore valves 504 to remove fluid from one or more tubes 500, andtherefore, to remove fluid from one or more chambers 496 viaperforations 36.

As illustrated in FIG. 53, a compressible member 498, such as a piece offoam or other porous material or non-porous material, can be disposedbetween inner layer 50 and outer layer 52 and within a chamber 496 tomaintain patency under a compressive force such as negative gaugepressure (e.g., suction) and additionally retraction forces presentduring surgery. Additionally, the outlet conduit 68 may be connected toone or more chambers 496 in the surgical access device 8 c.

Not all perforations 36, joined locations 492, joined lengths 494,chambers 496, tubes 500, and valves 504 are labeled in FIGS. 48-53 tomake the Figures easier to see.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately,” “about,” and “substantially” may refer to an amountthat is within less than 10% of, within less than 5% of, within lessthan 1% of, within less than 0.1% of, and within less than 0.01% of thestated amount.

The term “up to about” as used herein has its ordinary meaning as knownto those skilled in the art and may include 0 wt. %, minimum or tracewt. %, the given wt. %, and all wt. % in between.

Elements or components shown with any embodiment herein are exemplaryfor the specific embodiment and may be used on or in combination withother embodiments disclosed herein.

While the invention is susceptible to various modifications andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives thereof.

What is claimed is:
 1. A method for retracting tissue in a surgical sitein a body, the method comprising: inserting at least a portion of asurgical access device into an incision, wherein the surgical accessdevice comprises a first retention member, a second retention member,and a pliable membrane coupled to the first retention member and thesecond retention member wherein the pliable membrane comprises an innerlayer and an outer layer with a space therebetween and a plurality ofperforations in the outer layer; advancing the first retention memberinto the body through an incision; disposing the second retention memberoutside the body; preventing separation of the inner layer from theouter layer with a plurality of joined locations at which the innerlayer and the outer layer are coupled to each other, wherein theplurality of joined locations form a plurality of chambers; irrigatingthe surgical site with fluid delivered through the space and from theplurality of perforations in the outer layer of the pliable membrane viaa first fluid path such that the fluid contacts a wall of the surgicalsite; passing the fluid through some of the chambers without passing thefluid through other chambers; and suctioning at least a portion of thefluid into the first retention member via a second fluid path after thefluid contacts the wall of the surgical site, wherein the first fluidpath is fluidly independent of the second fluid path.
 2. The method ofclaim 1, further comprising retracting the tissue using the pliablemembrane.
 3. The method of claim 1, further comprising supplying thefluid to the pliable membrane by passing the fluid through an inletconduit fluidly coupled to the pliable membrane.
 4. The method of claim1, further comprising removing fluid from the first retention member bypassing fluid through a fluid removal member coupled to the firstretention member.
 5. The method of claim 1, wherein the first retentionmember comprises a hollow ring.
 6. The method of claim 1, furthercomprising maintaining patency between the inner and outer layers byproviding a porous or non-porous material disposed in the spacetherebetween, wherein the porous or non-porous material maintainspatency when a compressive force is applied to the inner and outerlayers.
 7. The method of claim 6, further comprising retaining the fluidin the porous or non-porous material.
 8. The method of claim 1, furthercomprising maintaining patency between the inner and outer layers byproviding a compressible or incompressible material disposedtherebetween, wherein the compressible or incompressible materialmaintains patency when a compressive force is applied to the inner andouter layers.
 9. The method of claim 1, wherein the fluid comprises anantibiotic fluid.
 10. The method of claim 1, wherein the fluid comprisesa saline solution.
 11. The method of claim 1, wherein the fluidcomprises a diagnostic or therapeutic agent.
 12. The method of claim 1,wherein the fluid comprises an analgesic agent or analgesic solution.13. A method for retracting tissue in a surgical site in a body, themethod comprising: inserting at least a portion of a surgical accessdevice into an incision, wherein the surgical access device comprises afirst retention member, a second retention member, and a pliablemembrane coupled to the first retention member and the second retentionmember wherein the pliable membrane comprises an inner layer and anouter layer with a space therebetween and a plurality of perforations inthe outer layer; advancing the first retention member into the bodythrough an incision; disposing the second retention member outside thebody; preventing separation of the inner layer from the outer layer witha plurality of joined locations at which the inner layer and the outerlayer are coupled to each other, wherein the plurality of joinedlocations form a plurality of chambers; irrigating the surgical sitewith fluid delivered through the space and from the plurality ofperforations in the outer layer of the pliable membrane such that thefluid contacts a wall of the surgical site; passing the fluid throughsome of the chambers without passing the fluid through other chambers;and while irrigating the surgical site, suctioning at least a portion ofthe fluid into the first retention member after the fluid contacts thewall of the surgical site.
 14. The method of claim 13, wherein the fluidcomprises an antibiotic fluid.
 15. The method of claim 13, wherein thefluid comprises a saline solution.
 16. The method of claim 13, whereinthe fluid comprises a diagnostic or therapeutic agent.
 17. The method ofclaim 13, wherein the fluid comprises an analgesic agent or analgesicsolution.